Flexible composite suture having a tandem linkage



March 28, 1967 s. SIN ERMAN ETAL 3,311,110

FLEXIBLE COMPOSITE SUTURE HAVING A TANDEM LINKAGE Filed July 15, 1964 TORS.

/v N K 7 7 ATTORNEY f lfllllfg a United States Patent of Maine Filed July 15, 1964, Ser. No. 382,877 4 Claims. (Cl. 128-3355) This invention relates to a needled surgical suture in which, in order, are an eyeless surgical needle, in the butt end of which is crimped' a flexible suture leader, which leader is joined by a crimped connector sleeve to a stiff relatively brittle surgical suture.

In the placing of stiff surgical sutures, such as a'monofilament stainless steel suture, or other stiff metal suture, or a large collagen suture, or even a stainless steel suture of few comparatively large strands, the suture is too stiff to permit convenient insertion by the surgeon. The stiffness of the suture introduces an additional force which tends to deflect the path of the surgical needle during insertion. Further, stainless steel, as well as many other stiff materials tend to work harden when bent beyond their elastic limit. If flexed several times during insertion the suture tends to bend principally at the point of attachment to a needle. If the end of the stiff suture is crimped into the butt end of an eyeless needle, the suture may work harden and break. The existence of the problem does not appear to have been recognized in a manner leading to an adequate solution.

US. Patent 1,960,117, E. H. Lydeard, Surgical Needle or the Like and Suture Therefor, May 22, 1934', shows the coupling of a metal link to the end of a suture,

which link is attached to a spring eyed needle as an improvement to avoid doubling the suture through a needle eye, and yet permit multiple use of needles.

US. Patent 2,302,986, H. B. Volrath, Atraumatic Suture Link, Nov. 24, 1942, shows an improved linkage to attach a suture removable and flexibly to the eye of an eyed needle. (Atraumatic Register No. 203,122, dated Sept. 8, 1925, and renewed, is a trademark of American Cyanamid Company.)

U.S. Patent 2,591,063, H. Goldberg, Surgical Suture, Apr. 1, 1952, discloses an eyeless needle attached to a tantalum wire which in turn is attached to that portion of a suture which is left in the tissuesf This suture is designed to be used as a pre-placed suture with the metal wire adjacent to the incision during a cutting .step to prevent accidentally nicking the suture, with the metal wire being used to later pull the final suture into position. As eye sutures, the diameter is disclosed as from 0.001 to 0.009 inch, and hence flexibility is no problem.

US. Patent 3,125,095, D. Kaufman et al., Flexible Stainless Steel Sutures, Mar. 17, 1964, discloses and claims a polyfilamentary flexible stainless steel suture with each filament less than about 0.0018 inch, and about 19 or more filaments to provide flexibility.

We have now found that stiff sutures may -be conveniently laced by inserting a flexible suture leader between an eyeless needle and a stiff relatively brittle surgical suture having a diameter of at least 0.006 inch.

Flexibility is a problem primarily in sutures where the diameter is at least 0.006 inch, a size 5-0 suture, and larger. Sutures of stainless steel or other metal of size 4-0, 0.008 inch, or 000, 0.010 inch, become increasingly subject to work hardening and breakage during placement.

The suture of the present invention is illustrated in the accompanying drawings in which:

FIGURE 1 is a view of the assembled suture.

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FIGURE 2 is an enlarged adjacent section II of FIG- URE 1 showing the attachment of the flexible suture leader to the eyeless needle.

FIGURE 3 is an enlargement showing the connector sleeve crimping the flexible suture needle to a stiff relatively brittle surgical suture, at section III.

FIGURE 4 is a view of a connector as shown in III, except that a double drilled connector sleeve is used.

As shown in FIGURE 1, the present needled suture consists of an eyeless surgical needle 11. This is a threecornered cutting edge needle, reverse cutting edge needle, a duck billed needle, or other needle having the cross section and curvature preferred for a particular surgical procedure. The tissue piercing end 12 is sharp and of conventional size and configuration. At the butt end of the needle 13, the needle is either drilled or flanged to provide a hole 14 in which a flexible suture leader 15 is crimped. The flexible suture leader is preferably of a readily sterilizable plastic such as nylon, linear polyethylene, isotactic polypropylene, polyester, silk or other proteinaceous fiber. The flexible suture leader may be braided or twisted but a monofilament flexible suture leader usually has completely acceptable flexibility and handleability and is more economical and less apt to have contaminants trapped therein. The flexible suture leader may be somewhat longer than the eyeless surgical needle so that in use the needle itself is drawn completely through the tissues before the connector sleeve 17 enters the tissues. Whereas a longer flexible suture leader is preferred for very large sutures, for smaller sizes, the leader can be as short as A3" or less. With smaller size sutures flexibility is less of a problem, and breakage at the point of attachment is the only major consideration. At the trialing end of the flexible suture leader is crimped of a stiff relatively brittle surgical suture 16 by means of a connector sleeve 17.

The connector sleeve 17 may be of thin walled metal tubing, preferably seamless and preferably of a high strength material such as stainless steel, as shown in FIGURE 3. The connector sleeve may be of a short length of double drilled rod, as shown in FIGURE 4. It needs to be strong enough that there is no danger of the connector failing and small enough to follow the flexible suture leader through the tissues. Preferably the sleeve has a diameter not greater than that of the surgical need so as to avoid additional damage to the tissues during penetration. Theoretically, a short segment of a surgical needle 18 itself could be used with both ends drilled, as shown in FIGURE 4, but such a configuration is apt to be more expensive than seamless tubing. The tubing itself may be seamed but the presence of a seam introduces a possible zone of weakness, and contamination.

The connector sleeve is crimped to both the flexible suture leader and the stiff relatively brittle surgical suture firmly enough that the crimp does not fail during 7 use.

The stiff relatively brittle surgical suture 16 is of a work hardenable material such as monofilament stainless steel, monofilament tantalum, or in the larger sizes, may be of from 3 to 7 or more individual ends of metal such as stainless steel, each at least 0.006 inch diameter, where the finshed suture is of such size that even this number of filaments is apt to work harden and break from flexure during use by the surgeon. Such large polyfilament stiff sutures can be used to join b'ones, or major abdominal elements. Even large catgut sutures may be undesirably stiff, and subject to flex failure.

The flexible suture leader may be considerably longer than the minimum required, which permits the surgeon to easily flex the suture leader during placement and yet permits the use of a stiff suture where a large and stiff to permit use of the bone sooner.

size is required for strength and/ or rigidity in the tissues in the patient. In suturing bones together, for instance, it may be desirable that the suture be of stainless steel and of such rigidity as to furnish support during healing, In other instances, a strong stifi suture, such as a stainless steel suture, is preferred by a surgeon during a major abdominal 'operation in which the surgeon desires to have a few large stiff sutures to retain tissues in position during at least part of the healing process.

Other variations in structure, such as for example, the configurations of the hole in the butt end of the needle or in the connector to prevent slippage and the sizeof both the flexible suture leader and the stiff relatively brittle surgical suture are a matter of choice within the skill'of. the art, depending upon the surgical procedure of choice.

As exemplary 'of theadvantages of introducing the flexible suture leader, tests were run by crimping a monofilament stainless steel wire of 18-8 stainless steel in a drilled-end needle. The drilled-end needle was crimped with the suture extending vertically downward from the needle. 18" from the butt of the needle a laboratory weight was attached to the suture. With the needle held clamped in a metal clamp, the weight was moved about 14%." off center and allowed to swing free as a pendulum, with the swings being counted until the suture snapped, or if the weight swung as a pendulum through more than 75 complete cycles, or double swings the pendulum was started over again to insure full amplitude. With no connecting link and a size 5-0 suture, using No. 34 B & S gauge wire (00063") a test weight of 200 grams was used as the pendulum. The number of cycles before breaking was successively 8, 13, 11, 7 and 12 for an average 'of about cycles.

Under similar conditions, but using about A" of 3-0 monofilament nylon leader suture, the weight swung 320 cycles without breaking, and without evidence of failure,

, at'which point the test was stopped.

Using about A3" of 50 monofilament nylon leader, a with 200 gram weight, cycles of 40, 96, 153 and 232 for an average of 130 cycles were obtained.

Using a stainless steel mu-ltifilament wire as leader, having a construction of 19 individual wires having a diameter of 0.0012 each, cycles of 10, 12, 15, 26 and 27 for an average of 18 cycles were obtained.

Similarly, a size 4-0 stainless steel suture consisting bf No. 32 B & S gauge stainless steel wire with a diameter of 0.00795" was used as a suture and was crimped in an eyeless needle which was suspended vertically with a 500 gram weight tied in the suture 18" from the point of Using the same 4-0 stainless steel monofilament suture,

4 a leader of 3-0 flexible multiple strand wire of seven strands each of seven wires 0.0012", and a 500 gram weight, the flexible leader gave tests of 106, 43, 79 and 79 cycles for an average of 77 to breakage.

Using a 4-0 monofilament stainless steel suture, and a 4-0 monofilament nylon flexible suture linkage, with a 200 gram weight,.over 320 cycles and no breakage was obtained. A full 500 gram weight pulled the leader loose from the needle or connector.

The monofilament steel suture had a straight pull strength of approximately 2.8 kg. for the 4-0 and 1.54 kg. for the 5-0 suture. This shows that the embrittlement, work hardening and fracture occurs at the base of the needle long before the full strength of the wire is devel oped. The introduction 'of the present flexible suture leader permits the surgeon to use a monofilament stainless steel suture with a minimum risk of work hardening and breaking and yet with the preferred flexibility and bendability required for convenience in. emplacing the suture.

The above tests are exemplary rather than definitive of the advantages to be obtained by using a flexible suture leader in accordance with the present invention.

Having described embodiments thereof as our invention, we claim:

1. A needled surgical suture comprising:

(a) a flexible suture leader, having a front and back end,

(b) an eyeless surgical needle, having inserted and crimped in the butt end thereof the front end of said flexible suture leader,

(0) a stiff, relatively brittle, metallic surgical suture, having a diameter of at least 0.006 inch, having a front and back end,

(d) a connector sleve crimped to and joining the back end 'of said flexible suture leader to the front end of said suture,

(e) the said leader having such length that the exposed portion between said needle and said sleeve is about /8 inch, and the order being the needle, the leader, the connector, and then the suture.

2. The suture of claim 1 in which the flexible suture leader is a monofilament of a plastic selected from the group consisting of nylon, linear polyethylene, isotactic polypropylene, polyester, silk and proteinaceous fiber.

3. The suture of claim 1 in which the stiff, relatively brittle, metallic, surgical suture is a monofilament.

4. The suture of claim 3 in which the stiff, relatively brittle, metallic, surgical suture is stainless steel.

References Cited by the Examiner UNITED STATES PATENTS 2,591,063 4/1952 Goldberg l28339 X 3,130,728 4/1964 Pearson et al 128-3355 3,152,591 lO/1964 King l28335.5

RICHARD A. GAUDET, Primary Examiner;

DALTON L. TRULUCK, Examiner. 

1. A NEEDLED SURGICAL SUTURE COMPRISING: (A) A FLEXIBLE SUTURE LEADER, HAVING A FRONT AND BACK END, (B) AN EYELESS SURGICAL NEEDLE, HAVING INSERTED AND CRIMPED IN THE BUTT END THEREOF THE FRONT END OF SAID FLEXIBLE SUTURE LEADER, (C) A STIFF, RELATIVELY BRITTLE, METALLIC SURGICAL SUTURE, HAVING A DIAMETER OF AT LEAST 0.006 INCH, HAVING A FRONT AND BACK END, (D) A CONNECTOR SLEVE CRIMPED TO AND JOINING THE BACK END OF SAID FLEXIBLE SUTURE LEADER TO THE FRONT END OF SAID SUTURE, (E) THE SAID LEADER HAVING SUCH LENGTH THAT THE EXPOSED PORTION BETWEEN SAID NEEDLE AND SAID SLEEVE IS ABOUT 1/8 INCH, AND THE ORDER BEING THE NEEDLE, THE LEADER, THE CONNECTOR, AND THEN THE SUTURE. 